Formulation Optimization & Evaluation of Co-Processed Excipients for Orally Disintegrating Tablet of Bilastine

The development of novel excipients with enhanced functionality has been explored through particle engineering techniques such as co-processing. This study aimed to improve the direct compression properties of banana powder by co-processing it with microcrystalline cellulose (MCC) in optimized proportions using the solvent evaporation method. The resulting co-processed excipient (CPE) was evaluated for its flow and compaction properties in comparison to its individual components and their physical mixture. Orally disintegrating tablets (ODTs) containing 20 mg of Bilastine were formulated using the optimized CPE via direct compression. The tablets were assessed for critical quality attributes, including Flowability, compressibility, disintegration time, and drug release. Application of Design of Experiments (DoE) using Central Composite Design (CCD) enabled effective optimization of the excipient composition. The optimized batch (CPE5) showed excellent performance with an angle of repose of 25.32°, Carr’s index of 15.57%, Hausner’s ratio of 1.1557, disintegration time of 10.5 seconds, drug content of 96.86%, and drug release of Bilastine is 94.53% within 10 minutes, confirming its suitability for or dispersible tablet formulations. The optimized co-processed formulation demonstrated superior performance, with significantly improved disintegration and mechanical properties compared to conventional blends. The study concludes that co-processing banana powder with MCC successfully enhanced its functionality for use in direct compression and offers a robust platform for the development of fast-disintegrating Bilastine tablets.